North Carolina State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates QCOR (See below)
- Pay your CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
North Carolina Division of Health Service Regulation, Public Health Division. Clinical Laboratories.
(1) The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
(2) Contact Information Mailing Address: Division of Health Service Regulation/CLIA Certification, 2713 Mail Service Center, Raleigh, NC 27699-2713 Telephone: 919-855-4620
For changes or other requests: DHSR.CLIA@dhhs.nc.gov
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.